MAUDE Adverse Event Report: TYRX, INC AIGIS-R MEDIUM; MESH, SURGICAL, POLYMERIC

Model Number	CMRM6122
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	04/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products:ddmb1d1 icd, implanted: (b)(6) 2018; cmrm6122 antibacterial envelope implanted: (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that five days after implant of the implantable cardioverter defibrillator (icd) the pocket was opened to remove a hematoma.At the time of the pocket revision an antibacterial envelope was placed around the device.Cultures taken revealed no organisms were identified.Approximately one month following the pocket revision, the icd and leads were removed due to infection.Later, the patient received a new icd system.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was later reported there was vegetation.

• Brand Name: AIGIS-R MEDIUM
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): TYRX, INC; 1 deer park dr; suites g, e; monmouth jct NJ 08852
• MDR Report Key: 7456457
• Report Number: 3005619263-2018-00046
• Device Sequence Number: 13693799
• Product Code: FTL
• UDI-Device Identifier: 00643169935891
• UDI-Public: 00643169935891
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K130943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2018
• Device Model Number: CMRM6122
• Device Catalogue Number: CMRM6122
• Device Lot Number: R095734
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/18/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 05/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 694765 LEAD, 5076-52 LEAD
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 75 YR